How a problem is fixed at its cause rather than at the instance. A single failed batch is a rejection; a pattern is a system problem and is handled as one.
Document control
Document reference
LZ-SOP-QA-03
Revision
2
Effective from
February 6, 2026
Next review due
February 6, 2027
Document owner
Quality Assurance
Covers
CAPA
Provisions
Every deviation, complaint and out-of-specification result is logged and assessed for a wider cause
Corrective action addresses the cause; preventive action addresses whether the same cause can arise elsewhere
Actions carry an owner and a due date, and are verified as effective before closure
A recurring cause at one manufacturing source triggers re-qualification or a change of source, not repeated rejection
Scope. This document forms part of the Lyze Labs quality system and applies to
research reference material supplied for in vitro laboratory use. It is not a
marketing authorisation, a regulatory approval, or a claim that material may be used
in humans.
Document control. LZ-SOP-QA-03 is an internal controlled document reference in
the Lyze Labs namespace. It is not an accreditation or certification number issued by
an external body. A superseded revision is archived rather than destroyed, so what was
in force on any given date can be established.